GQL · Class II · 21 CFR 866.3305

FDA Product Code GQL: Antisera, Fluorescent, Herpesvirus Hominis 1,2

Leading manufacturers include Zeus Scientific, Inc., Syva Co. and Immulok, Inc..

37
Total
37
Cleared
123d
Avg days
1977
Since

FDA 510(k) Cleared Antisera, Fluorescent, Herpesvirus Hominis 1,2 Devices (Product Code GQL)

37 devices
1–24 of 37
Cleared Aug 28, 2009
ELVIS HSV ID AND D3 TYPING TEST SYSTEM
K091753
Diagnostic Hybrids, Inc.
Microbiology · 73d
Cleared Apr 01, 2009
LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT
K081527
Millipore Corporation
Microbiology · 303d
Cleared May 26, 1999
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984120
Zeus Scientific, Inc.
Microbiology · 189d
Cleared May 26, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984135
Zeus Scientific, Inc.
Microbiology · 189d
Cleared Nov 07, 1991
INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
K905608
Stellar Bio Systems, Inc.
Microbiology · 328d
Cleared Feb 01, 1991
HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPING
K904095
California Integrated Diagnostics, Inc.
Microbiology · 148d
Cleared Dec 13, 1990
PATHODX HERPES TYPING
K904167
Diagnostic Products Corp.
Microbiology · 93d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jul 31, 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662
Baxter Healthcare Corp
Microbiology · 43d
Cleared Jun 20, 1989
HSV-1 ELISA TEST SYSTEM
K891162
Zeus Scientific, Inc.
Microbiology · 106d
Cleared Jun 20, 1989
HSV-2 ELISA TEST SYSTEM
K891782
Zeus Scientific, Inc.
Microbiology · 88d
Cleared Jun 06, 1989
ORTHO HSV 1&2 DICHROMATIC TYPING REAGENT & SLIDES
K891382
Ortho Diagnostic Systems, Inc.
Microbiology · 89d
Cleared Jun 04, 1987
HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2
K870814
Microscan Div. Baxter Healthcare Corp.
Microbiology · 93d
Cleared Oct 10, 1985
DIAGNON HERPES IMMUNOPEROXIDASE TYPING TEST
K851635
Diagnon Corp.
Microbiology · 175d
Cleared Sep 12, 1985
ORTHO DNA PROBE HSV CONFIRMATION TEST
K852360
Ortho Diagnostic Systems, Inc.
Microbiology · 100d
Cleared Jul 30, 1985
PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMP
K852125
Kallestad Laboratories, Inc.
Microbiology · 76d
Cleared Jul 12, 1985
CELLMATICS HERPES SIMPLEX VIRUS DETECT-SYS
K851372
Difco Laboratories, Inc.
Microbiology · 95d
Cleared Mar 13, 1985
GIBCO HERPES ID KIT
K841943
Gibco Laboratories Life Technologies, Inc.
Microbiology · 306d
Cleared Mar 11, 1985
AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT
K850739
Syva Co.
Microbiology · 24d
Cleared Jan 29, 1985
CULTURESET HSV ISOLATION & ID SYS
K842216
Ortho Diagnostic Systems, Inc.
Microbiology · 239d
Cleared Jan 18, 1985
MICROTRAK HSV 1 & 2 DIRECT SPECIMAN
K841190
Syva Co.
Microbiology · 303d
Cleared Oct 30, 1984
SCOTT SELECTICULT-HSV ISOLATION &
K841680
Scott Laboratories, Inc.
Microbiology · 190d
Cleared May 07, 1984
MICROTRAK HSV 1 & 2 CULTURE
K840494
Syva Co.
Microbiology · 91d
Cleared Sep 20, 1983
HERPES IDENT. & TYPING TEST HITT
K831504
Electro-Nucleonics Laboratories, Inc.
Microbiology · 132d

About Product Code GQL - Regulatory Context